Trial Outcomes & Findings for Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis (NCT NCT02727907)

NCT ID: NCT02727907

Last Updated: 2023-02-17

Results Overview

Number of Combined Unique Active Lesions (CUA) -- the number of new MRI contrast uptake lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice) after 52 weeks blinded application of interferon-β1а (BCD-033 and Rebif®) (44 mcg).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 163 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2023-02-17

Participant Flow

Participant milestones

Measure	BCD-033 Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif/BCD-033 Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo/BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Overall Study STARTED	53	56	54
Overall Study Recived One Injection of Drug	53	55	54
Overall Study COMPLETED	40	43	43
Overall Study NOT COMPLETED	13	13	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis

Baseline characteristics by cohort

Measure	BCD-033 n=53 Participants interferon beta-1a (BCD-033)	Rebif / BCD-033 n=55 Participants interferon beta-1a (Rebif / BCD-033)	Placebo / BCD-033 n=54 Participants placebo / interferon beta-1a	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	55 Participants n=7 Participants	54 Participants n=5 Participants	162 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	28.00 years n=5 Participants	30.00 years n=7 Participants	29.5 years n=5 Participants	29.0 years n=4 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	31 Participants n=7 Participants	34 Participants n=5 Participants	103 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	59 Participants n=4 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: The primary endpoint was assessed after 52 weeks of use of IFN-β1a (BCD-033 and Rebif) in a full dose (44 μg). In the analysis of the effeciency of MRI indicators included 100 patients

Number of Combined Unique Active Lesions (CUA) -- the number of new MRI contrast uptake lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice) after 52 weeks blinded application of interferon-β1а (BCD-033 and Rebif®) (44 mcg).

Outcome measures

Measure	BCD-033 n=44 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=46 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Number of Combined Unique Active Lesions	0.0 lesions Interval 0.0 to 1.25	0.0 lesions Interval 0.0 to 1.0	—

SECONDARY outcome

Timeframe: 52 weeks

Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=55 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Annual Relapse Rate	0.113 relapses Standard Deviation 0.375	0.091 relapses Standard Deviation 0.348	0.109 relapses Standard Deviation 0.369

SECONDARY outcome

Timeframe: 16, 52 weeks

Population: The analysis was performed in per protocol population at 16 and 52 weeks

proportion of subjects without confirmed relapse in PP

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=51 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=51 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Proportion of Subjects Without Confirmed Relapse week 16	49 Count of Participants	46 Count of Participants	45 Count of Participants
Proportion of Subjects Without Confirmed Relapse week 52	41 Count of Participants	44 Count of Participants	39 Count of Participants

SECONDARY outcome

Timeframe: 96 weeks

Time to first relapse in "per protocol" population

Outcome measures

Measure	BCD-033 n=40 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=45 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Relapse Free Time	207.0 days Interval 52.0 to 276.0	183.0 days Interval 26.0 to 286.0	—

SECONDARY outcome

Timeframe: 96 weeks

CUA (the number of new contrast-enhanced lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice)

Outcome measures

Measure	BCD-033 n=44 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=46 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Number of Combined Unique Active Lesions	0.0 lesions Interval 0.0 to 2.0	0.0 lesions Interval 0.0 to 2.0	—

SECONDARY outcome

Timeframe: 96 week

Annual Relapse Rate ARR for 96 weeks was evaluated in two groups, after the administraion of IFN beta-1a in a full dose for 96 weeks.

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Annual Relapse Rate	0.208 relapses Standard Error 0.532	0.145 relapses Standard Error 0.524	—

SECONDARY outcome

Timeframe: 16, 52 weeks

Population: The analysis was performed in per protocol population at 16 and 52 weeks

Time to first relapse in "per protocol" population

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=51 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=51 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Relapse Free Time week 16	33.5 days Interval 12.0 to 60.0	14.0 days Interval 12.0 to 26.0	15.0 days Interval 5.0 to 61.75
Relapse Free Time week 52	193.0 days Interval 51.5 to 240.0	123.5 days Interval 22.5 to 204.75	74.0 days Interval 25.0 to 210.0

SECONDARY outcome

Timeframe: 16 weeks

CUA (the number of new contrast-enhanced lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice).

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=51 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=51 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Number of Combined Unique Active Lesions	0.0 lesions Interval 0.0 to 2.0	0.0 lesions Interval 0.0 to 1.0	1.0 lesions Interval 0.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 96 weeks

quantity and grade of all AE/SAE is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Adverse Events/Serious Adverse Events	124 adverse events	110 adverse events	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 weeks

AE grade 3-4 (CTCAE 4.03) is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=54 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Severe Adverse Events Frequency	5 adverse events	4 adverse events	7 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: 16, 52 weeks

quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=54 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Withdrawal week 16	0 Participants	1 Participants	1 Participants
Withdrawal week 52	1 Participants	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 16, 52 weeks

Count of Participants with Binding and Neutralizing Antibodies

Outcome measures

Measure	BCD-033 n=51 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=49 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=53 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Immunogenicity week 16 : Binding Antibodies	6 participants	5 participants	2 participants
Immunogenicity week 16 : Neutralizing Antibodies	5 participants	5 participants	2 participants
Immunogenicity week 52 : Binding Antibodies	10 participants	9 participants	7 participants
Immunogenicity week 52 : Neutralizing Antibodies	9 participants	8 participants	7 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 16, 52 weeks

quantity and grade of all adverse reactions/serious adverse reactions is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=54 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Adverse Reaction/Serious Adverse Reactions week 16	67 adverse events	59 adverse events	33 adverse events
Adverse Reaction/Serious Adverse Reactions week 52	92 adverse events	80 adverse events	92 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: 96 weeks

AE grade 3-4 (CTCAE 4.03)is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Severe Adverse Events Frequency	2 adverse events	3 adverse events	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 96 weeks

quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Withdrawal	1 Participants	1 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 96 weeks

Count of Participants with Binding and Neutralizing Antibodies

Outcome measures

Measure	BCD-033 n=51 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=49 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Immunogenicity Binding Antibodies	19 participants	14 participants	—
Immunogenicity Neutralizing Antibodies	16 participants	13 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 week of study

quantity and grade of all SAE is calculated in subjects, who received at least one dose of study drug

Outcome measures

Measure	BCD-033 n=53 Participants Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 Participants Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo / BCD-033 n=54 Participants Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Serious Adverse Events	0 adverse events	0 adverse events	3 adverse events

Adverse Events

BCD-033

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Rebif

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo/BCD-033

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	BCD-033 n=53 participants at risk Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 participants at risk Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo/BCD-033 n=54 participants at risk Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
Renal and urinary disorders nephrotic syndrome	0.00% 0/53 • 52 week	0.00% 0/55 • 52 week	1.9% 1/54 • Number of events 1 • 52 week
Eye disorders Left hemophthalmos	0.00% 0/53 • 52 week	0.00% 0/55 • 52 week	1.9% 1/54 • Number of events 1 • 52 week
Infections and infestations Chronic viral hepatitis B	0.00% 0/53 • 52 week	0.00% 0/55 • 52 week	1.9% 1/54 • Number of events 1 • 52 week

Other adverse events

Measure	BCD-033 n=53 participants at risk Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks	Rebif n=55 participants at risk Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks	Placebo/BCD-033 n=54 participants at risk Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage
General disorders headache	5.7% 3/53 • 52 week	5.5% 3/55 • 52 week	5.6% 3/54 • 52 week
General disorders flu-like syndrom	28.3% 15/53 • 52 week	29.1% 16/55 • 52 week	35.2% 19/54 • 52 week
General disorders fever	13.2% 7/53 • 52 week	10.9% 6/55 • 52 week	11.1% 6/54 • 52 week
Investigations increased ALT	5.7% 3/53 • 52 week	7.3% 4/55 • 52 week	5.6% 3/54 • 52 week
General disorders local reaction	28.3% 15/53 • 52 week	21.8% 12/55 • 52 week	18.5% 10/54 • 52 week
Investigations lymphopenia	9.4% 5/53 • 52 week	7.3% 4/55 • 52 week	7.4% 4/54 • 52 week
Investigations neutropenia	20.8% 11/53 • 52 week	7.3% 4/55 • 52 week	18.5% 10/54 • 52 week
Investigations thrombocytopenia	5.7% 3/53 • 52 week	9.1% 5/55 • 52 week	5.6% 3/54 • 52 week

Additional Information

Linkova Yuliya

BIOCAD

Phone: +7(495)9926628

Email: linkova@biocad.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place